Classes
DEA Class; Rx
Common Brand Names; Osmolex ER, Gocovri
- Antiparkinson Agents, Dopamine Agonists;
- Antivirals, Influenza
Description
Synthetic antiviral agent with dopamine agonist properties
Used primarily for motor symptoms of Parkinson’s disease (PD) or drug-induced EPS; an extended-release product can be used as an adjunct to carbidopa-levodopa in PD patients experiencing ‘off’ episodes
Not recommended by CDC for treatment or prophylaxis of influenza A infection due to resistant strains
Indications
Indicated for the treatment of idiopathic Parkinson disease (Paralysis Agitans), postencephalitic Parkinsonism, and symptomatic Parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication
Indicated for treatment of Parkinson disease
Indicated for adjunctive treatment to levodopa/carbidopa for Parkinson disease in patients experiencing “off” episodes
Indicated for dyskinesia in patients with Parkinson disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Indicated in the treatment of drug-induced extrapyramidal reaction
Contraindications
Tablet, syrup, capsule
- Hypersensitivity to amantadine, rimantadine
- Untreated narrow-angle glaucoma
- Breastfeeding
Extended-release capsule or tablet
- End-stage renal disease (CrCl<15 mL/min/1.73m²)
Adverse Effects
Extended-release capsule (Gocovri)
- Hallucinations (21%)
- Dizziness (16%)
- Dry mouth (16%)
- Peripheral edema (16%)
- Constipation (13%)
- Fall (13%)
- Orthostatic hypotension (13%)
- Urinary tract infection (10%)
- Nausea (8%)
- Anxiety (7%)
- Insomnia (7%)
- Livedo reticularis (6%)
- Contusion (6%)
- Depression/depressed mood (6%)
- Headache (6%)
- Benign prostate hyperplasia (6%)
- Decreased appetite (6%)
- Abnormal dreams (4%)
- Blurred vision (4%)
- Cough (3%)
- Pigmentation disorder (3%)
- Dystonia (3%)
- Confusional state (3%)
- Vomiting (3%)
- Gait disturbance (3%)
- Cataract (3%)
- Dry eye (3%)
- Joint swelling (3%)
- Muscle spasms (3%)
Immediate-release tablet/capsule or syrup
- Nausea
- Dizziness/lightheadedness
- Insomnia
- Depression
- Anxiety and irritability
- Hallucinations
- Confusion
- Anorexia
- Dry mouth
- Constipation
- Ataxia
- Livedo reticularis
- Peripheral edema
- Orthostatic hypotension
- Headache
- Somnolence
- Nervousness
- Dream abnormality
- Agitation
- Dry nose
- Diarrhea
- Fatigue
Warnings
Reports of falling asleep while engaged in activities of daily living (eg, operation of motor vehicles); patients may not perceive warning signs, such as excessive drowsiness, or they may report feeling alert immediately prior to the event; advise patients of the potential to develop drowsiness
Avoid abrupt withdrawal; abrupt discontinuation of amantadine may cause an increase in symptoms of Parkinson disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech
In clinical trials, suicidal ideation, depression, and/or depressed mood were reported; monitor for depression, including suicidal ideation or behavior
Pregnancy and Lactation
No adequate data on developmental risk associated with amantadine use in pregnant women; animal studies suggest a potential risk for fetal harm with amantadine; in mice and rats, adverse developmental effects (embryo lethality, increased incidence of malformations, and reduced fetal body weight) were observed when amantadine was administered to pregnant animals at clinically relevant doses
Amantadine is excreted into human milk, but amounts have not been quantified; there is no information on the risk to a breastfed infant; amantadine may alter breast milk production or excretion
Maximum Dosage
400 mg/day PO for immediate-release capsules, oral solution, or tablets; 274 mg/day PO for extended-release capsules; 322 mg/day PO for extended-release tablets.
400 mg/day PO for immediate-release capsules, oral solution, or tablets; 274 mg/day PO for extended-release capsules; 322 mg/day PO for extended-release tablets.
Immediate-release capsules, oral solution or tablets: 200 mg/day PO.
Extended-release capsules or tablets: Safety and efficacy have not been established.
9 years and older: 200 mg/day PO for immediate-release capsules, oral solution, or tablets. Safety and efficacy of extended-release capsules and tablets have not been established.
1 to 8 years: 8.8 mg/kg/day PO or 150 mg/day PO, whichever is less for immediate-release capsules, oral solution, or tablets. Safety and efficacy of extended-release capsules and tablets have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Amantadine hydrochloride
capsule or tablet, immediate-release (generic)
100mg
syrup (generic)
50mg/5mL
capsule, extended-release (Gocovri)
68.5mg
137mg
tablet, extended-release (Osmolex ER)
129mg
193mg
258mg
